Medication (de)Prescribing in Hospitalized Geriatric Patients With Sarcopenia, Less is More
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 160
- 主要终点
- Deprescribing
研究概览
简要总结
The goal of this clinical trial is to compare the effects of a deprescribing pharmacotherapy approach to the STOPP-START approach (usual care) in geriatric patients with sarcopenia and polypharmacy. The main question it aims to answer is the number and type of medication that can be stopped in this population without being restarted within 6 months.
After inclusion a medication review is performed by a team consisting of the researcher, a geriatrician and a hospital pharmacist, according to the protocol within which the patient was randomised. Participants are follow up at appointments after 1, 3 and 6 months. At these appointments, questionnaires are administered about the quality of life and complications related to medication.
详细描述
Rationale Acutely ill hospitalized geriatric patients have co-morbid disease and polypharmacy and 2/3 have low muscle strength and low muscle mass, called sarcopenic. Although all efforts are done by the multidisciplinary team to combat health problems and negative sequalae of sarcopenia, 80% of the (severely) sarcopenic patients will be deceased within 2 years. Optimalization medication is part of this multidisciplinary treatment strategy. The STOPP START criteria are applied to optimize the polypharmacy. However, it is not known whether this strategy actually results in a better or worse outcome for these patients. The question that arises is whether it is even better to minimize pharmacotherapy in these patients and only apply it if the aim is to combat symptoms and complaints and to stop (preventive) medication as much as possible. The latter is called a deprescribing pharmacotherapy approach (DPA) and seemed to be successful in a previous study concerning older frail patients.
Objective:
The effects of DPA compared to STOPP-START approach (SSA) prescribing on adverse drug reactions, medical complications, hospital readmission, quality of life in hospitalized geriatric patients with sarcopenia
Study design:
Prospective randomised intervention study. Patients will be randomised in two groups: intervention group (IG) with a DPA of 80 patients and an control group (CG) of 80 patients with a SSA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 70 years and older
- •Being frail according the Groningen Frailty Indicator (GFI score >3)
- •Severely sarcopenic according the European Working Group On Sarcopenia-2 criteria (EWGSOP-2) based on handgrip strength (men < 27kg and women < 16kg), appendicular skeletal muscle mass (men < 7,0 kg/m2 and women < 5,5 kg/m2) and physical function below cut-off values (Short Physical Performance Battery <9)
- •The use of 5 or more different medications before hospitalization
排除标准
- •Being not instructible
- •Having an implantable cardioverter defibrillator (ICD)
- •No informed consent can be optained with the participant or a legal representative
结局指标
主要结局
Deprescribing
时间窗: 6 months
The number and type of medication stopped and not restarted during medication review and number and type of medication restarted within 1, 3 and 6 months
次要结局
- Complications due to medication(6 months)
- Hospital readmission(6 months)
- Adverse Drug Reactions (ADR)(6 months)
- The quality of life(6 months)
- Mortality(6 months)